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Regorafenib + Immunotherapy for Colorectal Cancer
Study Summary
This trial is studying regorafenib in combination with ipilimumab and nivolumab to see if it can help to treat patients with colorectal cancer that has spread and is resistant to chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607Trial Design
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Who is running the clinical trial?
Media Library
- I had cancer before, but it's not skin cancer or certain in situ cancers, and I'm not currently undergoing treatment.I have brain metastases but am stable, not on high steroids, or my steroid dose is stable or decreasing.My colorectal cancer is MSI-H.I have previously been treated with regorafenib or immune checkpoint inhibitors.I have severe diarrhea or a major digestive disorder like Crohn's.My liver enzymes are within the allowed range for my cancer condition.I have not had a heart attack or unstable chest pain in the last 6 months.I haven't had cancer treatment within the last 14 days or 5 half-lives of the drug.My colorectal cancer is not microsatellite unstable.My condition worsened after treatment with specific medications.I don't have major side effects from previous treatments, except for anemia, hair loss, or skin changes.My colon or rectum cancer is advanced, spreading, and not responsive to certain DNA repair errors.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of bleeding disorders, regardless of severity.I have not had severe bleeding in the last 28 days.I have an immune system disorder or am on high-dose steroids or other drugs that weaken my immune system.I am currently receiving treatment for a serious infection.My kidney function, measured by creatinine levels, is within the required range.I haven't had any blood clots or strokes in the last 3 months.My urine test shows high protein but less than 3.5 g/24 hr.I do not have irregular heartbeats that are uncontrolled.I have tested positive for hepatitis B or C.I have not received a live vaccine within the last 30 days.My cancer's RAS and BRAF gene status is known.I have been diagnosed with HIV.My blood pressure is often over 150/90 mmHg, even with treatment.I have not had major surgery or significant injury in the last 28 days.My tumor sample was taken within the last 6 months after my last cancer treatment.I have an autoimmune disease but it's either mild or well-controlled.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My heart condition limits my physical activity.I can swallow and absorb pills.I have a history of lung scarring or fibrosis.I have had pneumonitis treated with steroids or have it now.I can provide a recent sample of my tumor for the study.I agree to use birth control during the study and for some months after.I have a wound, ulcer, or bone fracture that is not healing.
- Group 1: Treatment (regorafenib, nivolumab, ipilimumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the indications for Regorafenib?
"Regorafenib is a common treatment for unresectable melanoma, as well as squamous cell carcinoma and other high-risk forms of cancer with the potential for recurrence."
Are there any limitations on the number of participants recruited for this clinical trial?
"Unfortunately, this trial is not accepting new candidates as of now. Initially posted on May 27th 2020 and last updated August 22nd 2022, other options are available with 1989 studies actively recruiting colorectal cancer patients while 809 trials require Regorafenib participants."
Are there any previous experiments that have evaluated the effectiveness of Regorafenib?
"Currently, 809 medical trials are studying the efficacy and safety of Regorafenib with 91 studies in Phase 3. Although most of these experiments take place in Pittsburgh, Pennsylvania; 43504 other locations around the world have joined this research project."
Is there an ongoing recruitment period for this research study?
"This medical experiment is no longer enrolling patients, with the initial posting on May 27th 2020 and last update occurring on August 22nd 2022. Fortunately there are numerous other studies that still need people to participate; 1989 trials are seeking individuals suffering from colorectal cancer while 809 experiments require participants for Regorafenib treatments."
Has Regorafenib received official sanction from the Food and Drug Administration?
"Regorafenib's safety score is a 1 since this is still at the Phase I stage in terms of clinical trials. This indicates that there is limited data to support its efficacy and safety profile."
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